Lack of Assurance of Sterility
Prescription Drugs
💊 Drugs • 11,927 recalls
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Healthful Naturals Leg Cramp Support Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906 NDC 68703-206-02
Silver Star Brands
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Tesamorelin, 1mg/vial, 6mL vial, Lyophilized Powder for Reconstitution and Subcutaneous Injection, Rx Only, Tailor Made Compounding, Nicholasville, KY 40356
Tailor Made Compounding
Labeling: Incorrect or Missing Lot and/or Expiration Date; vial indicates a 1 year expiration date instead of a 6 month expiration date
Native Remedies VertiFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-253-02
Silver Star Brands
Microbial Contamination of Non-Sterile Products
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Bi-Mix Injection, (Alprostadil 40 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Houston, Texas --- NDC 69699-1305-03
Pharm D Solutions
Lack of Assurance of Sterility
Phenylephrine 25 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
Avella of Deer Valley, Inc. Store 38
Lack of assurance of sterility
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Dexpanthenol Injection, 250 mg/mL Pharm D Solutions, Houston, Texas --- NDC 69699-1610-30
Pharm D Solutions
Lack of Assurance of Sterility
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Water Sterile for Injection 250 mL IV Pharm D Solutions, Houston, Texas --- NDC 69699-1407-25
Pharm D Solutions
Lack of Assurance of Sterility
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.